Abstract PO1-28-07: Neoadjuvant docetaxel plus cisplatin versus docetaxel plus doxorubicin and cyclophosphamide in early-stage triple-negative breast cancer (HNBC-001): results from a multicenter, randomized controlled, open-label phase II trial

Abstract Background: Adding platinum to anthracycline- and taxane-based neoadjuvant chemotherapy has improved pathological complete response (pCR) in patients with triple-negative breast cancer (TNBC). However, the efficacy of combining docetaxel and platinum without anthracycline remains controversial. Methods: The HNBC-001 trial was a randomized, phase 2 controlled, and open-label investigation carried out in China at 6 hospitals. The participants who were aged 18–70 years, were histologically confirmed for TNBC clinical stage II–III, suitable for potentially curative surgery, and had an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1 were selected for this trial. Participants were randomly categorized into two equal groups; those who received docetaxel plus cisplatin (75 mg/m2, respectively) and those who received docetaxel plus doxorubicin and cyclophosphamide (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2). These regimens were given every 3 weeks for 6 cycles. Randomization was stratified by tumor size and nodal status. The primary endpoint was the number of individuals achieving a pCR (ypT0/is ypN0). The trial was registered with chictr.org (number ChiCTR-1800019501). Results: Between November 28, 2018, and June 11, 2022, 212 patients were selected (n=106/treatment). The number of individuals who achieved pCR after docetaxel plus cisplatin treatment was 51.9%, and that of those who attained pCR after docetaxel plus doxorubicin and cyclophosphamide was 35.8% (P=0.019). After 21 months of median follow-up [interquartile range (IQR), 13 to 33], 11 of 106 patients (10.4%) in the docetaxel plus cisplatin group and 14 of 106 patients (13.2%) in the docetaxel plus doxorubicin and cyclophosphamide group had event-free survival (EFS) events [95% confidence interval (CI) =0.360 to 1.783, hazard ratio (HR) =0.801, P=0.585]. The incidence of grade 3 or 4 events was similar in both groups [57 (54%) vs. 51 (48%)]. However, no treatment-associated deaths were identified. Conclusions: In stage II to III TNBC, the docetaxel plus cisplatin regimen achieved higher pCR rates than docetaxel plus doxorubicin and cyclophosphamide, with a manageable toxicity profile. Consistent with the literature, the docetaxel plus cisplatin regimen demonstrated a favorable risk-to-benefit profile and could serve as an optimal neoadjuvant chemotherapy option for patients with high-risk TNBC. table 1: Patient characteristics figure 1: Study endpoints Error bars denote 95% CIs based on normal approximation. p values were calculated from the Chi-square test. (A) Frequency of patients who achieved a pathological complete response per treatment group (primary endpoint). (B) Frequency of patients who achieved a clinical breast tumour response per treatment group, assessed by serial MRI scans after completion of neoadjuvant treatment. (C) Frequency of patients who achieved a minimal residual disease (residual cancer burden class 0 or 1). (D) Frequency of patients who received breast-conservation surgery. table 2: Treatment-emergent adverse events Citation Format: Dechuang Jiao, Jianghua Qiao, Chengzheng Wang, Juntao Li, Xianfu Sun, Zhenduo Lu, Chongjian Zhang, Lianfang Li, Min Yan, Yueqing Feng, Yong Zhou, Miao Deng, Xinlan Liu, Mingde Ma, Haiquan Jia, Qingxin Xia, Xiuchun Chen, Zhenzhen Liu. Neoadjuvant docetaxel plus cisplatin versus docetaxel plus doxorubicin and cyclophosphamide in early-stage triple-negative breast cancer (HNBC-001): results from a multicenter, randomized controlled, open-label phase II trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-28-07.